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September 25, 2020

Health Law Daily

FDA Grants Emergency Use Authorization For First Point-Of-Care SARS-CoV-2 Antibody Test

  • September 25, 2020

Medscape (9/24, Brooks, Subscription Publication) reports the FDA “approved the first point-of-care (POC) antibody test for [SARS-CoV-2], under an emergency use authorization (EUA).” Back in July, the agency granted an EUA to Assure Tech’s Assure COVID-19 IgG/IgM Rapid Test Device “for use in certain laboratories to help identify people with antibodies to SARS-CoV-2, an indicator of recent or prior infection.” Now with “the new POC authorization, the test can be performed in physicians’ offices, hospitals, urgent care centers, and emergency departments.”